Guidance 1.1 Patients with recurrent malignant glioma (brain cancer) who have failed first-line chemotherapy treatment with other agents (either because of lack of efficacy or because of side effects) may be considered for treatment with temozolomide. Such patients must have a histologically proven malignant glioma (WHO grades III and IV, or transformed grade II) at first relapse, recurrence or progression (as assessed by imaging), Karnofsky performance status greater than or equal to 70 and a projected life expectancy of 12 weeks or more, at initiation of temozolomide treatment.
1.2 Temozolomide is not recommended for first-line chemotherapy treatment for patients with malignant glioma who have failed primary therapy (surgery and/or radiotherapy), except in the context of a randomised controlled trial against a standard-treatment comparator.
1.3 As temozolomide is not currently licensed for adjuvant chemotherapy treatment of malignant glioma, its use in this indication has not been considered in this appraisal.